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首页> 外文期刊>AIDS >The 3-year renal safety of a tenofovir disoproxil fumarate vs. a thymidine analogue-containing regimen in antiretroviral-naive patients.
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The 3-year renal safety of a tenofovir disoproxil fumarate vs. a thymidine analogue-containing regimen in antiretroviral-naive patients.

机译：初次使用抗逆转录病毒药物的替诺福韦富马酸替索罗非酯与含胸苷类似物的方案的3年肾脏安全性。

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BACKGROUND: Cases of renal dysfunction in patients receiving tenofovir disoproxil fumarate (TDF) have been reported. We analyzed the renal safety of TDF compared with thymidine analogue-containing (control) regimens through 144 weeks from two clinical trials in antiretroviral-naive HIV-infected patients. METHODS: We evaluated the changes in renal parameters in 1111 patients (TDF, n = 556; control, n = 555) who were enrolled in two randomized, controlled trials (Studies 903 and 934) comparing TDF vs. either stavudine or zidovudine in combination with efavirenz and either lamivudine or emtricitabine. The studies included patients with serum creatinine less than 1.5 mg/dl, serum phosphorus at least 2.2 mg/dl and estimated glomerular filtration rate by Cockcroft-Gault at least 60 and at least 50 ml/min at screening. RESULTS: Baseline characteristics were similar between groups. No patient discontinued due to renal abnormalities in the TDF arm. Through 144 weeks, the proportion of patients who experienced confirmed abnormalities in serum creatinine (>1.5 mg/dl) or serum phosphorus (<2.0 mg/dl) was less than 1% in both groups; a similar proportion of patients experienced urine proteinuria at least 100 mg/dl (TDF, 5%; control, 6%). The median change from baseline to week 144 in glomerular filtration rate was -2 and 3 ml/min by Cockcroft-Gault, and -2 and -1 ml/min per 1.73 m by modification of diet in renal disease in the TDF and control groups (P < 0.05), respectively. CONCLUSION: In two randomized, controlled trials, small differences in glomerular filtration rate over time were noted but no clinically relevant renal disease or adverse events were demonstrated in antiretroviral-naive patients treated with TDF through 144 weeks. Additional studies on renal health and renal safety in HIV are important goals for future clinical trials.
机译：背景：已经报道了接受替诺福韦酯富马酸二甲吡咯酯（TDF）患者的肾功能不全的病例。在未经抗逆转录病毒治疗的HIV感染患者的两项临床试验中，我们通过144周分析了TDF与含胸苷类似物（对照）方案的肾脏安全性。方法：我们评估了1111名患者（TDF，n = 556;对照组，n = 555）的肾脏参数变化，该患者参加了两项随机对照试验（研究903和934），比较了TDF与司他夫定或齐多夫定的联合治疗与依非韦伦和拉米夫定或恩曲他滨合用。这些研究包括血清肌酐低于1.5 mg / dl，血清磷至少2.2 mg / dl，Cockcroft-Gault估计的肾小球滤过率至少为60和至少50 ml / min的患者。结果：各组之间的基线特征相似。没有患者因TDF组的肾脏异常而中断。在144周内，两组患者血清肌酐（> 1.5 mg / dl）或血清磷（<2.0 mg / dl）的异常患者比例均低于1％;相似比例的患者尿蛋白尿至少达到100 mg / dl（TDF，5％;对照，6％）。在TDF组和对照组中，通过肾脏疾病的饮食控制，Cockcroft-Gault从基线到第144周的中值变化为-2和3 ml / min，每1.73 m分别为-2和-1 ml / min （P <0.05）。结论：在两项随机对照试验中，注意到随着时间的推移，肾小球滤过率随时间的变化很小，但未接受过抗逆转录病毒治疗的初次使用TDF的患者在144周内未发现临床相关的肾脏疾病或不良事件。有关HIV的肾脏健康和肾脏安全性的其他研究是未来临床试验的重要目标。

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